JP2017506980A - Suture anchoring system and delivery method - Google Patents

Abstract

The present invention relates, in various embodiments, to devices, methods, and systems for anchoring surgical sutures, and more specifically to a selectively lockable suture anchor. A system and method for anchoring a suture in various limited access surgical procedures includes a suture anchor having a displaceable section for selectively locking a portion of the suture to the suture anchor. Is used. A series of anchors and optional suture locks may be used in a continuous or interrupted stitch pattern, depending on the application.

Description

(Cross-reference of related applications)
This application claims the benefit of priority to US Provisional Patent Application No. 61 / 948,030, filed March 5, 2014, which is hereby incorporated by reference in its entirety. Incorporated inside.

  The present invention relates, in various embodiments, to devices, methods, and systems for anchoring surgical sutures, and more specifically to a selectively lockable suture anchor.

  Suture anchors are available for several purposes, including but not limited to flexible endoscopy, laparoscopic and robotic surgery, orthopedic surgery, skin closure, and percutaneous image guidance procedures It may be employed in clinical applications. Suture anchors are also used to attach various medical devices such as stents, physiological sensors, wireless cameras, or surgical meshes to specific anatomical locations such as the gastrointestinal (GI) tract. Also good. Advantageously, with respect to suture tethering, the suture can be cut endoscopically or laparoscopically to facilitate device removal, or the use of an absorbable type of suture is delayed, spontaneous May allow migration.

  For example, for GI endoscopy, a suture anchor may be used to approximate a tissue layer, a section of tissue within a single tissue layer, or an adjacent lumen wall. Tissue access using an anchor can also facilitate several types of percutaneous medical procedures, such as feeding tube placement or drainage procedures. For percutaneous feeding tube placement, an anchor with a continuous suture can be placed percutaneously, for example, in the lumen of the stomach or small intestine, and then the suture is tightened and the anchor removes the organ. For example, it can be locked so as to approach the abdominal wall. This practice may allow for safe percutaneous feeding tube insertion directly into the stomach or jejunum, for example. In a similar manner, tissue anchors placed in the colon or gallbladder can facilitate direct drainage tube insertion in the context of an obstruction.

  The suture anchor can also approximate two separate lumens to facilitate the production of internal folds. For example, a suture anchor placed in the loop from the stomach to the jejunum brings these two organs closer together, bypassing gastric pyloric obstruction, or as part of a malabsorption obesity procedure Can be used to promote the production of gastrojejunostomy. A suture anchor placed in the bile tree or gallbladder from the duodenum or stomach can also help generate biliary digestive tract anastomoses to relieve bile duct pressure and abdominal pain.

  Suture anchors are also used to repair esophageal hiatal hernia and alleviate signs of gastroesophageal reflux disease by delivering suture anchors through the esophageal wall and diaphragm muscle to prevent relative movement Also good. A suture anchor may also be delivered through the esophageal wall, diaphragm muscle, and fundus for repair to approximate partial fundoplication.

  In addition, an anchor can be inserted around the GI tract perforation to subsequently close the defect and subsequently the attached suture can be tightened. However, in GI endoscopy, the current configuration of suture anchors has some limitations. For example, depending on the specific model, these limitations may include (1) the need for endoscopic removal and reinsertion for each individual anchor placement, (2) the ability to perform only intermittent suture placement, (3) the ability to place only one set of continuous sutures, (4) the need for a separate suture tightening / locking device, (5) the need for a separate suture cutting mechanism, and / or (6) This includes the inability to place additional sutures using the same device after the suture has been cut. Some devices for placing endoscopic sutures involve a suture delivery mechanism that is attached to the outside of the endoscope, but these devices may be used depending on the anatomical location. It can be very cumbersome and difficult.

  For laparoscopic or robotic surgery, suture anchors with continuous sutures are more efficient for surgical sutures compared to current minimally invasive techniques that mimic manual tying of surgical knots. Provide a method. For example, current laparoscopic and robotic surgical techniques for suturing involve a suturing needle that is manipulated at the end of a tool that is placed through a surgical port. However, current techniques typically require two access ports to perform this task, mimicking what a surgeon can do using both hands. More specifically, the first access port may be used, for example, to introduce a tool for grasping a needle with a suture, and the second access port may be, for example, a tissue that requires suturing. Can be used for tools to manipulate. Once the suture is in place, a surgical knot can be tied to tighten the suture and hold the suture in place. Because the suture anchor delivery needle can be small enough for portless percutaneous insertion into the abdominal cavity, significantly improved surgical access is achieved through simple repositioning of the delivery needle. obtain. Similarly, suture anchors placed percutaneously through tissue are used to temporarily retract the viscera and assist laparoscopic access and visualization without requiring additional laparoscopic ports. May be.

  With regard to orthopedic surgery, tissue anchors with continuous sutures provide a means to approximate the rupture of two damaged tissues, such as ligaments, tendons, or meniscus, or surgical implants to the desired tissue Can facilitate installation. In practice, tissue anchors with continuous sutures can provide a very efficient and safe means for closure of skin defects. However, current methods for skin closure with continuous stitches generally involve traversing the tissue plane back and forth and penetrating a needle with attached suture, and tying the surgical knot and The suture cutting continues. As knot tying and suture cutting can be required at each interrupted stitch, suture interrupting for skin closure is even more involved.

  In light of the shortcomings of current surgical techniques and devices, it is desirable to provide a single platform device for suture anchoring, suturing, and suture cutting. More specifically, it is desirable to provide a single platform device that allows for the generation of interrupted or continuous sutures and provides several advantages over current skin closure techniques. More specifically, devices, systems, and methods are addressed that address the current limitations of suture anchors and the unmet clinical need for a robust and easy-to-use suture platform in a very compact operating volume. Is desired.

  According to one embodiment, the system described herein extends slidably throughout and is aligned on the same axis and / or in parallel to provide an instrument channel for an endoscope or ultrasound endoscope Alternatively, it contains a series of anchors with sutures placed in a small diameter delivery system that can fit within the lumen. The small diameter of the delivery device may facilitate its use with other laparoscopic and robotic surgical tools via a single surgical port and / or without a separate surgical port, It may be used directly for skin or skin use. The unique configuration of suture anchors and associated delivery systems according to various embodiments provides for suture locking, suture cutting, and additional sutures using the same device on one or more desired anchors. Allows the ability to initiate thread placement. These innovative properties allow the ability to place multiple suture anchor placements and multiple interrupted or continuous sutures without the need for delivery device removal.

  In a first aspect, a suture tether system is provided. In some embodiments, the system includes a longitudinal axis extending from the proximal end to the distal end of the anchor and a displaceable section for locking a portion of the suture, such as a suture loop, Having a suture locking tab, a deformable connecting element, a suture engaging slot, a suture engaging tooth, a deflectable locking projection, a bridge element, a deformable strut, or a cantilever tab and is therefore locked The length of the suture portion includes an extension anchor that extends in the direction of the longitudinal axis. In some variations, the system may further include a suture. The anchor and / or suture may be made from a bioabsorbable material. In various embodiments, the displaceable section is made from a plastically deformable material and / or an elastically deformable material.

  In some implementations, the anchor may further include a fixation section having features for engaging the suture, such as a suture engagement slot, a suture engagement tooth, or a fixation tab. In some variations, the suture anchor further includes a plurality of tissue supports, an anti-rotation key engageable with a corresponding anti-rotation key of another anchor, a beveled distal tip, a sharp distal tip, a distal One or more of the blunt shoulders close to the tip and / or one or more of the connectors interlockable with the corresponding connector of another anchor to allow rotation of the anchor in a single plane May be included. In some variations, the anchor may define a lumen for slidably receiving the suture and / or the anchor defines a suture recess for receiving a portion of the suture. May be.

  In a second aspect, a system for delivering a suture anchor is provided. In some embodiments, the system includes a delivery needle and an anvil coupled to the delivery needle to lock the anchor to the suture within the delivery needle. In one variation, the anchor may include an engagement shoulder at the proximal and distal ends of the anchor. In some implementations, the system further includes one or more anchors positioned within the delivery needle, slidably extending through the anchor, a suture, a breakable connector between each anchor, and through the delivery needle. Push rod for advancing a plurality of anchors, a mechanism for retracting, tensioning and / or releasing the suture, and / or actuating an anvil and / or, for example, a delivery needle A locking edge may be included for cutting the suture using a slidable edge. In some variations, the delivery needle, each anchor, and the suture may be substantially coaxially aligned. In some implementations, the delivery needle may define a longitudinal slot for engaging the protruding tab of the anchor, and / or the delivery needle may have a sharp distal tip and / or a suture cutting cut. It may contain a notch. In one variation, the push rod includes an anti-rotation key that can mesh with the corresponding anti-rotation key of the anchor.

  In a third aspect, a method is taught for suturing tissue. In some embodiments, the method includes using the anvil to lock the anchor to the suture within the delivery needle and deploying the anchor from the delivery needle to the tissue site. The step of using the anvil includes actuating the anvil by displacing the locking tube relative to the anvil and / or displaceable section of the anvil (eg, by displacing the anchor with a push rod). And mechanically interfering with. In some implementations, the method further includes displacing the locking tube to cut the suture (eg, moving the locking tube longitudinally along the longitudinal axis of the delivery needle and And / or rotating the locking tube), approaching the tissue layer, approaching two separate lumens in the patient's body, closing the defect at the tissue site, and medical device at the tissue site, eg, stent, physiological One or more of using anchors and sutures to perform at least one of sensor, camera, surgical mesh, or equivalent anchoring may be included. In some variations, the method may further include advancing the delivery needle through the instrument channel of the endoscope to the tissue site.

  In a fourth aspect, a method for engaging tissue is taught. In some embodiments, the method includes inserting a tissue engagement tool proximate to a tissue site, the tissue engagement tool being coupled to a catheter and a distal end of the catheter. A step of rotating the helical coke screw element to engage the tissue site and then through the lumen of the catheter to the tissue site, such as a medical instrument, e.g., a tissue access device, a tissue suction needle, Delivering a biopsy forceps, a needle, a cryotherapy probe, and an RF ablation probe. In some variations, the method further includes cutting the suture using a cutting edge coupled to the distal end of the catheter.

  In a fifth aspect, a tissue engagement tool is provided. In some embodiments, the tool includes a catheter having a lumen for receiving a medical device and a cutting edge coupled to the distal end of the catheter, e.g., beveled radially inward. And a helical coke screw element coupled to the distal end of the catheter. In one variation, the helical coke screw element includes a sharp distal tip for engaging tissue.

  It should be understood that the features of the various embodiments described herein are not mutually exclusive and may exist in various combinations and permutations.

  Further features, embodiments and advantages of the present invention will become apparent from the following detailed description with reference to the drawings.

FIG. 1A shows a perspective view of an illustrative embodiment of a suture anchor according to the present invention.

FIG. 1B shows a cross-sectional view of a first embodiment of a selectively lockable suture anchor with a locking tab and a locking tab according to the present invention.

FIG. 1C shows a cross-sectional view of the selectively lockable suture anchor of FIG. 1B after the anvil has clamped the locking tab according to the present invention.

FIG. 1D shows a perspective view of a second embodiment of a selectively lockable suture anchor having a fixed section, a movable section, and a deformable connecting element according to the present invention.

FIG. 1E shows a perspective view of a third embodiment of a selectively lockable suture anchor having a locking mechanism according to the present invention.

FIG. 1F shows a perspective view of a fourth embodiment of a selectively lockable suture anchor having a locking mechanism according to the present invention.

FIG. 2A shows a perspective view of a selectively lockable suture anchor proximate to a delivery needle tip of a delivery and deployment system, according to an embodiment of the present invention.

FIG. 2B shows a cross-sectional view of a selectively lockable suture anchor disposed within a delivery needle, according to an embodiment of the present invention.

2C shows a cross-sectional view of the selectively lockable suture anchor and delivery needle of FIG. 2B with a bridging element riding over the anvil according to that embodiment of the invention.

2D illustrates a cross-sectional view of the selectively lockable suture anchor and delivery needle of FIG. 2B with the locking tube advanced to urge the anvil against the bridge element, according to that embodiment of the invention. Show.

2E illustrates a cross-sectional view of the selectively lockable suture anchor and delivery needle of FIG. 2D with the locking tube removed, according to one embodiment of the present invention.

2F shows a perspective view of an illustrative embodiment of a needle delivery system for delivering the suture anchor of FIG. 3G according to the present invention.

2G shows a perspective view of the needle delivery system of FIG. 2F deploying the suture anchor of FIG. 3G according to one embodiment of the present invention.

FIG. 2H shows a perspective view of the needle delivery system of FIG. 2G rotating the suture anchor of FIG. 3G according to one embodiment of the invention.

FIG. 2I shows a cross-sectional view of an illustrative embodiment of a needle delivery system for delivering a pair of anchors locked to a fixed length suture connection section according to the present invention.

FIG. 2J shows a cross-sectional view of the pair of anchors of FIG. 2I approaching the tissue lumen wall according to one embodiment of the present invention.

FIG. 3A shows a cross-sectional view of an illustrative embodiment of a double wiggle anchoring mechanism for a suture anchor according to the present invention.

FIG. 3B shows top and bottom perspective views of an exemplary embodiment of a double wiggle suture anchor according to the present invention.

FIG. 3C shows a perspective view of an illustrative embodiment of a suture anchor having a cylinder plane snap lock in accordance with the present invention.

FIG. 3D shows a cross-section of the snap lock of FIG. 3C according to the present invention.

FIG. 3E shows a perspective view of an illustrative embodiment of a suture anchor having an angled bridge element and two lower suture recesses in accordance with the present invention.

FIG. 3F shows a perspective view of an illustrative embodiment of a suture anchor having an angled strut leading to a single bridge and a single lower suture recess according to the present invention.

FIG. 3G shows a perspective view of an exemplary embodiment of a suture anchor having at least one cantilever tab in accordance with the present invention.

FIG. 4 shows a perspective view of an illustrative embodiment of a sharpened tip suture anchor in accordance with the present invention.

FIG. 5A shows a top perspective view of an illustrative embodiment of a bridge and tooth type suture anchor in accordance with the present invention.

5B shows a bottom perspective view of the bridge and tooth type suture anchor of FIG. 5A according to the present invention.

FIG. 6A shows a perspective view of an illustrative embodiment of a suture anchor with alignment tabs in accordance with the present invention.

6B shows a perspective view of an exemplary embodiment of a delivery needle having an alignment slot for use with the alignable suture anchor of FIG. 6A according to the present invention.

FIG. 7A shows a perspective view of an illustrative embodiment of a plurality of suture anchors having bevel interlock links according to the present invention.

FIG. 7B shows an enlarged perspective view of an exemplary embodiment of the interaction between the bevel interlock links of the suture anchor of FIG. 7A according to the present invention.

FIG. 8A shows a perspective view of an illustrative embodiment of a plurality of suture anchors having a breakable connector in accordance with the present invention.

8B shows an enlarged top perspective view of an illustrative embodiment of a breakable connector between adjacent suture anchors of FIG. 8A in accordance with the present invention.

FIG. 8C shows an enlarged bottom perspective view of the illustrative embodiment of the breakable connector of FIG. 8B in accordance with the present invention.

FIG. 8D shows details of an illustrative embodiment for breaking a breakable connection between adjacent suture anchors of FIG. 8B according to the present invention.

FIG. 9 shows an enlarged perspective view of an illustrative embodiment of a breakable connection between adjacent suture anchors with an engaging and disengaging shoulder, in accordance with an embodiment of the present invention.

FIG. 10A shows a perspective view of an illustrative embodiment of a needle delivery system for delivering and deploying a locked suture anchor according to the present invention.

FIG. 10B shows a perspective view of an illustrative embodiment of a needle delivery system for delivering and deploying an unlocked suture anchor according to the present invention.

FIG. 10C shows a perspective view of an illustrative embodiment of a needle delivery system that penetrates tissue to deliver and deploy a suture anchor according to the present invention.

FIG. 10D shows a perspective view of an illustrative embodiment of a needle delivery system for deploying a suture anchor according to the present invention.

FIG. 10E shows a perspective view of an illustrative embodiment of a needle delivery system that is removed from tissue after deployment of a suture anchor in accordance with the present invention.

FIG. 10F shows a perspective view of an illustrative embodiment of a needle delivery system that prepares a second suture anchor for delivery and deployment after deployment of the first suture anchor according to the present invention.

FIG. 10G shows a perspective view of an illustrative embodiment of a needle delivery system prepared for delivering and deploying a second suture anchor according to the present invention.

FIG. 10H shows a perspective view of an illustrative embodiment of a needle delivery system that locks a suture within a second suture anchor in preparation for tensioning a deployed suture according to the present invention. .

FIG. 10I shows a perspective view of an illustrative embodiment of a needle delivery system that is prepared for tensioning a deployed suture in accordance with the present invention.

FIG. 10J shows a perspective view of the illustrative embodiment of the needle delivery system of FIG. 10H where the locking tube is advanced to lock the suture within the second suture anchor, according to the present invention.

FIG. 10K shows a perspective view of the illustrative embodiment of the needle delivery system of FIG. 10J tensioning the deployed suture according to the present invention.

FIG. 10L shows a perspective view of an illustrative embodiment of a needle delivery system in preparation for suture cutting according to the present invention.

FIG. 10M shows a perspective view of the illustrative embodiment of FIG. 10L where the locking tube is advanced in preparation for suture cutting according to the present invention.

FIG. 10N shows a perspective view of the illustrative embodiment of FIG. 10M where the locking tube is rotated to cut the suture according to the present invention.

FIG. 10O shows a perspective view of an illustrative embodiment of a needle delivery system that includes a suture cutting notch according to the present invention.

FIG. 11A shows a perspective view of an illustrative embodiment of a suture lock according to the present invention.

FIG. 11B shows a perspective view of an illustrative embodiment of a needle delivery system containing a suture anchor and a suture lock according to the present invention.

12A-12E illustrate an exemplary embodiment of a method for approximating a tissue plane using a needle delivery system according to the present invention. 12A-12E illustrate an exemplary embodiment of a method for approximating a tissue plane using a needle delivery system according to the present invention. 12A-12E illustrate an exemplary embodiment of a method for approximating a tissue plane using a needle delivery system according to the present invention. 12A-12E illustrate an exemplary embodiment of a method for approximating a tissue plane using a needle delivery system according to the present invention. 12A-12E illustrate an exemplary embodiment of a method for approximating a tissue plane using a needle delivery system according to the present invention.

FIG. 13 illustrates an exemplary embodiment of a method for repairing meniscal cartilage using a needle delivery system according to the present invention.

FIG. 14 illustrates an exemplary embodiment of a handheld anchor delivery device for use with a needle delivery system according to the present invention.

FIG. 15A shows an illustrative embodiment of a helical tissue control tool for use with a needle delivery system according to the present invention.

FIG. 15B shows an illustrative embodiment of the helical tissue control tool of FIG. 15A positioned at a first tissue target site for use with a needle delivery system according to the present invention.

FIG. 15C shows an illustrative embodiment of the helical tissue control tool of FIG. 15A positioned at a second tissue target site for use with a needle delivery system according to the present invention.

FIG. 15D shows a schematic diagram of an illustrative embodiment of a suture cutting device for the helical tissue control rule of FIG. 15A according to the present invention.

FIG. 16 provides a table of representative system parameters according to various embodiments of the present invention.

  Referring to FIG. 1A, an illustrative embodiment of a selectively lockable suture anchor 160 according to the present invention is shown. In some implementations, the suture anchor 160 employs plastic or elastic deformation to lock the suture within the lumen 162 of the suture anchor 160. Thus, in such an implementation, the permanently implantable and lockable suture anchor 160 can be, for example, a metal implant grade material such as stainless steel (304 grade steel), nickel-titanium alloy, cobalt chrome alloy ( May be made from Elgiloy Specialty Metals), and equivalents, or implant grade polymers such as PEEK, PEKK, polyamides, self-reinforced polyphenylene, polyphenylsulfone, liquid crystal polymers, and the like. Alternatively, in some implementations, the suture anchor 160 may be designed to be bioabsorbable, and a bioabsorbable metal such as magnesium, iron, zinc, etc., or a biodegradable polymer, For example, made from poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly (D, L-lactide / glycolide) copolymer (PDLA), polycaprolactone (PCL), hyaluronic acid (HA), and the like May be.

  The selectively lockable suture anchor 160 is laser cut from metal or polymer tubing, stamped from sheet metal, injection molded, laser sintered from metal or polymer material, hot melt shaped. It may be 3D printed or manufactured using any suitable method.

  In some embodiments, the selectively lockable suture anchor 160 extends from the proximal end 164, the distal end 165, and from the proximal end 164 to the distal end 165 (shown as a dashed line 166). A longitudinal axis; a pair of lateral tissue supports 163; a centrally located suture loop or bridge 161; and a lumen 162 dimensioned to slidably receive the suture. Elongation device. The suture loop 161 and lumen 162 are combined with the tissue support 163 to provide a passage and mechanical clearance through which the suture can travel freely and slidably bidirectionally. Advantageously, the suture loop 161 slidably receives the suture in the unlocked state, but may be configured to be attached to the suture in the locked state.

The lumen 162 is sized to slidably receive the suture, but is slightly larger in diameter than the diameter of the suture to be contained therein, and thus the small scale of the suture loop 161. This deformation creates sufficient mechanical interference to lock the suture to the anchor 160. More specifically, the lumen diameter ( _Dal ) is sized to be slightly larger than the diameter of the suture to be contained therein, and the suture passes through the suture loop 161 to the channel of the tissue support 163. Sufficient radial clearance is left in lumen 162 for easy sliding along the slot. For example, for a non-absorbable 2-0 suture having a 0.012 inch diameter, a suitable diameter of the anchor lumen 162 may range from about 0.013 to about 0.020 inch. The suture loop 161, because it is intended to be deformed or bent to the suture, in some variations, the suture loop 161 spans about 25 to about 50 percent of the luminal diameter (D _al) An amount may project radially above the slotted portion of the tissue support 163.

  Further, in some implementations, the slotted portion of tissue support 163 is approximately luminal diameter wide while the open portion of tissue support 163 constitutes at least 180 degrees of the circumference of tissue support 163. The suture may therefore slide freely from the slotted portion.

  In some variations, the locked state eliminates mechanical clearance and crimps, compresses, deforms, or deforms a portion of the suture loop 161 to impact the suture within the lumen 162. It may be achieved by different displacement. Such deformation can be elastic or plastic, or elasto-plastic. Alternatively, locking may be achieved by urging the suture into a tight bend or tortuous path in the suture loop 161 to increase the friction between the suture and the anchor 160. Good.

  For example, in a first variation, referring to FIG. 1B, an elongated suture anchor 110 with a suture 115 is shown. As previously described, the suture 115 may be routed along the lumen 162 below the suture loop 125. The suture anchor 110 may include a tissue support 127 that is separated by a suture loop 125 that selectively engages a section of the suture 115 and locks the anchor 110 to the suture 115. May be configured. In some implementations, the suture loop 125 may include one or more plastically deformable locking tabs 120. In some variations, the suture loop 125 is axially aligned and engaged with at least one securing tab 121, optionally having a V-shaped or U-shaped cutout or cradle for guiding the suture 115. When in the stop release state, a free sliding opening 126 may be formed along the longitudinal axis of the anchor 110. In some cases, the locking tabs 120 are sufficiently close to each other on both sides of the locking tab 121 so that, when biased to the locked position, the suture 115 can be clamped against the locking tab 121. May be positioned.

  As shown in FIGS. 1B and 1C, the locking tab 120 is sufficient to prevent sliding, thereby locking the suture 115 relative to the anchor 110. 120 urges the suture 115 into a tortuous path around the distal and proximal ends of the locking tab 121 and / or the suture 115, eg, the distal and proximal ends of the locking tab 120. As well as into the path of the suture 115 by the delivery system anvil 130, eg, radially inwardly displaced by the movable locking tube 140 to mechanically engage the securing tab 121. It may be selectively deflected. As shown in FIG. 1C, the length of the locked suture portion extends in the direction of the longitudinal axis 166 of the anchor. The features and functionality of the delivery system are discussed in more detail below.

  In some embodiments, a suture lock 700 (FIG. 11A), described in more detail below, may be separate from the suture anchor 110 and is slidable relative to the suture 115 only. The suture anchor 110 may be used in combination. In such embodiments, a selectively engageable suture lock 700 is included between each suture anchor 110 in the delivery system or between multiple suture anchors 110 in the delivery system at various intervals. May be.

  As shown in FIG. 1D, in another embodiment, the selectively lockable suture anchor 130 provides a suture loop 146, one or more deformable connecting elements 140, and tissue support. And a fixed section 132. The suture loop 146 may include a movable section 131 having a plurality of suture engagement features 138, eg, suture engagement slots, suture engagement teeth, or other friction enhancing features. The securing section 132 may also include such a suture engaging feature 139. The movable section 131 and the fixed section 132 are brought closer together and engage the suture 115 once a force is applied to the movable section 131, eg, by the anvil 130. Connected by one or more plastically deformable connecting elements 140 constructed and arranged in such a manner. The suture engagement features 138, 139 may be configured as a continuous circumferential structure, including a deformable element, or configured as a non-continuous gap structure capable of permanent deflection through plastic deformation. May be. Again, as shown in FIG. 1D, the length of the locked suture portion extends in the direction of the anchor longitudinal axis 166.

  In yet another embodiment, as shown in FIG. 1E, a selectively anchorable suture anchor 150 includes a plurality of elastically deflectable locks on a movable (eg, hinged) section 151. It includes a suture loop 153 having features such as protrusions 155 and a fixed section 152 having engagement locking features such as teeth 154. In the locked position, the protrusion 155 of the suture loop 153 and the teeth 154 of the fixed section 152 may be in engaging contact to lock the movable section 151 to the fixed section 152. When so engaged, locking tabs 158 disposed at the proximal and distal ends of suture loop 153 and one or more securing tabs disposed between and above securing section 152 159 may lock a portion of the suture 115 so that the length of the locked suture portion extends in the direction of the longitudinal axis 166 of the anchor. As in the previously described embodiments, the selectively lockable suture anchor 150 is constructed using a continuous circumferential structural element that can accommodate displacement through deformation. And / or the selectively lockable suture anchor 150 may be configured as a discontinuous gap structure held together by a slidable interlocking element.

  In yet another embodiment, as shown in FIG. 1F, the suture anchor 174 may initially be restrained in an unlocked state within the lumen of the delivery needle 175. The locked state of the suture anchor 174 causes the elastically deformed portion 170 of the suture loop 171 to be in such a manner that the portion 173 of the elastically deformed portion 170 collides radially inward with the suture. It may be achieved by releasing. Mechanical friction created by the elastic restraint of the suture loop 171 may also prevent the anchor 174 from sliding prematurely from the delivery needle 175.

  The selectively lockable suture anchor 150 may be cut from the tubing by a laser or equivalent process and locking tabs 158, 159 may subsequently be formed at the desired location. Alternatively, the suture anchor 150 may be stamped from the sheet material and formed into a final shape via a progressive die stamping process.

  Advantageously, the suture locking mechanism or structure includes a protruding and extending portion of the suture lock that is fixed and / or movable axially away from the lock in both directions, and thus a T-shaped suture. It may be included within a suture anchor to form an anchor.

  An illustrative embodiment of a double wiggle type suture anchor is shown in FIGS. 3A and 3B. In FIG. 3A, first, the suture 330 slidably extending through the lumen of the suture anchor 300 is securely locked to the anchor 300 by deflection of the at least two bridge elements 310 into the anchor lumen. May be. Inward deflection of the bridge element 310 displaces a portion of the suture 330 into a corresponding gap formed as the lower suture recess 316. The gap between adjacent bridge elements 310 may form an upper suture recess 315. The plurality of bridge elements 310 deflected toward the lower suture recess 316 sufficiently increases the friction between the suture 330 and the anchor 300 and functionally locks the suture 330 to the anchor 300. The suture 330 is pushed in a zigzag or wavy pattern (eg, W-shaped). This configuration is advantageous to allow for a greater, less precise radial displacement of the locking suture loop or bridge 310 and may reduce the risk of the suture 330 breaking. Referring to FIG. 3B, the longitudinal openings on both sides of the bridge element 310 allow the suture 330 to be placed so that when the suture is tensioned, the installed anchor and suture are T-shaped in the tissue. For example, a suture slot 320 is provided that may be dimensioned to allow lateral sliding around the bridge element 310 from an anchor lumen.

  As shown in FIG. 3B, the suture anchor 300 also includes anti-rotation features 305 and 306 that can be configured to substantially circumferentially lock the anchors together to prevent relative rotation. Good. In some variations, the female anti-rotation key 306 may include an undercut feature 309 that can be dimensioned to receive the male anti-rotation key 305 of the adjacent suture anchor 300. Thus, the undercut that interlocks the anti-rotation features 305, 306 causes the anchors 220a, 220b to abut each other along the axis or longitudinal dimension as shown in FIG. While being restrained, it may be mechanically locked. Once the distal anchor 220a is substantially retracted from the delivery needle 210, it is free to separate from the more proximal anchor 220b and deploy from the delivery system 200. This configuration may be advantageous in preventing the anchors 220a, 220b from sliding away from each other and losing rotational alignment within the delivery needle 210. Interlocking the anti-rotation features 305, 306 can also help prevent unintentional sliding of the distal anchor 220 a from the distal tip of the delivery needle 210.

  Illustration of suture anchor 300A including a mechanical suture locking mechanism that employs a sliding surface and elastic deformation to hold bridge 370 in either a radially outward or radially inward position. An exemplary embodiment is shown in FIGS. 3C and 3D. Mechanical suture locks are firm (and optionally reversible) suture locks with a relatively low locking force compared to crimped suture locks or other plastic deformation based suture locks. Can be advantageous. Such a mechanical suture locking mechanism includes a deflectable bridge 370 having a wedge-shaped cross section that is dimensioned such that the radially inner edge 371 of the flexure opening is smaller than the radially outer edge 372 of the bridge 370. May be included. As a result, the bridge 370a elastically diffuses to the end of the locking flex 375 when it is moved radially inward against a similar wedge-shaped surface of the locking flex 375. Once the end bounces around bridge 370a, it can become trapped by flexure 375. In some variations, once locked in a radially inward position, the gap between the two bridging elements 370 may form an upper suture recess 377 and the bridge 370b may provide friction. In order to increase and lock the suture to the anchor 300A, some deflection of the suture into the lower suture recess 376 may be maintained. In some implementations, the lower recess 376 may also include a relatively sharpened feature, such as a toothed slot 520 as shown in FIG. 5B, to increase longitudinal friction, Will be discussed in more detail below.

  In one variation, as shown in FIG. 3E, the bridge 380 element may be angled with respect to the longitudinal axis of the suture anchor 300B. This configuration reduces the amount of radial mechanical force required to deform the bridge 380 radially inward so that it can displace the suture section into the lower suture recess 386. Can be particularly advantageous. In yet another variation, the lockable suture anchor 390 may include a single bridge 391 and a single suture recess 392, as shown in FIG. 3F. For example, the bridge 391 is configured to allow the bridge 391 to move radially inward so that it can push a portion of the suture into the lower suture recess 392. It may be supported by angled struts 393 that are plastically deformable.

  In yet another variation, a sharp tip suture anchor 1300 may be employed. For example, as shown in FIG. 4, an illustrative embodiment of suture anchor 1300 may include a sharpened distal tip 1310. Advantageously, in this configuration, suture anchor 1300 is first assisted by tissue penetration and then rotated to place suture anchor 1300 in or through the desired tissue. It may function to anchor the suture in a large surface area T position relative to the entry hole. The suture anchor 1300 may include a relatively blunt, eg, rounded or rounded shoulder 1320 located proximal to the sharp distal tip 1310. The main shoulder 1320 may be used to transmit an axial force between a series of anchors in the delivery needle while protecting the sharp distal tip 1310. The round shoulder 1320 minimizes resistance as the portion of the anchor proximate the sharp tip 1310 passes through the penetration site. Matching the anchor tips 1310 with each other using the trailing ends of adjacent anchors may also serve to limit the relative rotation between the anchors. The sharp tip configuration of anchor 1300 is not a larger delivery needle, but minimizes the overall size of tissue penetration by allowing suture anchor 1300 to form its own penetration. It can be advantageous and can find particular utility in thin or delicate tissues.

  In yet another variation, as shown in FIGS. 5A and 5B, the suture anchor 500 may include a bridge 510 that is supported by an elastically deformable strut 515 in combination with a toothed slot 520. . In use, the bridge 510 is displaced into the central lumen of the suture anchor by plastically deforming the struts 515 and defines a portion of the suture that, in some implementations, is narrower than the suture diameter. It may be forced into a toothed slot 520 that can be dimensioned. The bridge 510 may optionally include suture facing teeth as depicted. The deformation of the relatively soft suture section into the relatively hard toothed slot 520 further ensures that the suture locks into the anchor 500.

  In yet another variation, as shown in FIG. 3G, suture anchor 300C is configured to lock a portion of the suture within central lumen 523 when deformed, for example, by an anvil. One or more cantilever tabs 521 may be included. FIG. 3G shows two cantilever tabs 521, but this is shown for purposes of illustration and not limitation. In practice, those skilled in the art will appreciate that the number of cantilever tabs 521 can be greater than or less than two. A gap 522 that separates the distal (ie, cantilevered) end of each cantilever tab 521 from the sidewall 524 of the suture anchor 300C provides the cantilever tab 521 (ie, compresses and locks a portion of the suture). Thus, for example, the anvil may be dimensioned to prevent the suture from sliding from the lumen 523 while it is not deformed (prior to the tab 521 being bent radially inward). In some variations, the gap 522 is further dimensioned so that the bent or deformed cantilever tab 521 does not mechanically interfere with the sidewall 524 of the anchor 300C after the tab 521 is bent or deformed.

  For example, in some applications where there are multiple anchors disposed within the delivery needle, it may be advantageous to maintain rotational alignment of the suture anchor within the delivery system. Thus, one or more structural features may be integrated into the suture anchor to assist in aligning the anchor with other anchors along the longitudinal length of the delivery system. In one embodiment, as shown in FIGS. 6A and 6B, one or more suture anchors 900 are configured to engage alignment slots 930 formed in the wall of delivery needle 920. A tab 910 may be included. The protruding tab 910 may be located anywhere on the anchor 900, including anywhere along the center of the suture loop 905 or one or both of the tissue supports 906. The alignment slot 930 may be located anywhere on the circumference of the delivery needle 920, but in some embodiments it is located within the unsharpened tail 921 of the distal tip of the delivery needle 920. To do. In some embodiments, the alignment slot 930 may terminate proximate to the needle bevel so that the protruding tab 910 is always deflected radially inward and retracts from the delivery needle 920.

  In another embodiment, the slot 930 edge may be inwardly or abducted to engage a portion of each anchor and maintain rotational alignment. In various other embodiments, the delivery needle and anchor may have an asymmetric cross section that may include a non-cylindrical portion, such as a D-type or other flat surface, that prevents rotation. Alternatively, the delivery needle and anchor may have a symmetrical cut surface, eg, square, hexagonal, or the like, to maintain anchor alignment. In addition, each anchor may have a radial ridge at the proximal end that directly engages and meshes with a corresponding radial ridge at the distal end of the next proximal anchor.

  In another variation, referring to FIGS. 7A and 7B, a selectively lockable suture anchor 101 arranged end-to-end to facilitate loading into a delivery needle, for example, for each suture The thread anchors 101 may be interconnected by interlocking links 102 disposed at the distal end 165 and proximal end 164 of the thread anchor 101. In addition, at its distal end 165, each anchor 101 includes an angled surface 103 (ie, a beveled distal tip) with sufficient clearance for rotation (eg, in a single plane) adjacent. It may be possible to occur between the anchors 101a, 101b. Link features 102a, 102b are located radially from the longitudinal axis of each anchor. The tension applied to the suture extending through the anchor's central lumen 104 creates a moment that pivots the anchor 101a at the junction of the interlocking feature 102 (eg, in a single plane) and disengages. Tend to promote.

  In another variation, as shown in FIGS. 8A-8D, a series of suture anchors 201 may comprise a single piece of material, such as stainless steel hypotubes, a bioerodible material (such as magnesium), a bioabsorbable material. (Such as hyaluronic acid) and the like. Anchor 201 may include one or more breakable connectors 202 configured to also act as a rotating hinge. In some implementations, the connector 202 may be configured such that the hinge rotation can mechanically distort the connector 202 to the point of break and thus break the connection between adjacent anchors 201a, 201b.

  In some embodiments, the connector 202 is oriented relatively circumferentially such that the connector twists in response to relative rotation of adjacent anchors 201a, 201b, forming a hinge between the anchors 201a, 201b. May be. The connector 202 may be relatively short and narrow so that mechanical strain is concentrated on the connector itself and, as it rotates, can facilitate work hardening and breakage 204 as shown in FIG. 8D. Further, in some embodiments, the connector 202 can generate a torque moment that tension on the suture in the central lumen tends to rotate adjacent anchors 201a, 201b around the connector 202. The suture anchor 201 may be located substantially laterally on the same side of the center axis of the line or row.

  In some implementations, referring to FIG. 9, the breakable suture anchor 400 is mechanically applied to the contact point 403 after, for example, an angular displacement has occurred and the connector has not yet separated but is completely broken. It may be constructed and arranged to include detachable shoulders 401 and 402 that are configured to abut. The shoulders 401, 402 form a lever fulcrum where the contact point 403 tends to shift away from each other so that the remainder of the broken connector is separated from each other as rotation continues, thus the newly split anchor 400a. , 400b may be configured to be mutually free. For example, contact may occur at a relative rotation angle A in the range of about 90 degrees to about 160 degrees between anchors, for example, about 110 degrees.

  Although several embodiments of selectively lockable suture anchors with various locking mechanisms have been described, a system for deploying and delivering suture anchors and / or other medical devices is now described. Will be described in detail. Referring again to FIG. 2A, an illustrative embodiment of a dual wiggle type anchor deployment and delivery system 200 in the same plane is shown. In some implementations, the system 200 may include a delivery needle 210 that can be enclosed within and coaxial with the locking tube 260. The delivery needle 210 may be hollow with a cylindrical or generally cylindrical shape and form a lumen for receiving anchors and sutures. The shape of the delivery needle 210 has been described as cylindrical or generally cylindrical, but this is for illustrative purposes only. Those skilled in the art will recognize that the delivery needle 210 and its lumen are optional as long as the shape allows the delivery needle 210 to fit within the lumen of the locking tube 260 and serve its purpose during the surgical procedure. It will be understood that it may have a shape.

  At the distal end 203, the delivery needle 210 includes, for example, a sharpened distal tip for penetrating the patient's epidermis, tissue, etc., and a suture anchor 220, suture 230, medical device, etc. from the delivery needle 210. And an opening that can be withdrawn. The lumen formed by the delivery needle 210 provides a space through which the suture anchor 220, suture 230, medical device, etc. can slidably pass. The suture anchor 220 facilitates a close sliding fit within the lumen of the delivery needle 210, as well as to allow the suture 230 to slide within and through each suture anchor 220. May be dimensioned with sufficient radial clearance to do so.

  In some applications, the delivery needle 210 may include at least two slots 215 that extend longitudinally in the cylindrical wall to the distal needle tip of the delivery needle 201. The slot 215 is a piece that is an anvil 240 whose distal end is thicker (in the radial direction) than the cylindrical wall of the delivery needle 201 and can optionally be contoured, depending on the configuration of the anchor locking feature. It may be configured to provide a cantilever 216. The cantilever 216 allows the anvil 240 to be displaced radially within the delivery needle 210 when a radial force is applied to the anvil 240. As a result, the cantilever 216 may be configured to plastically deform as the anvil 240 is radially displaced either outward or inward. For example, in addition to crimping or clamping the suture lock locking tab 120 (or other displaceable sections of the various locking mechanisms described above), the anvil 240 may also include a subsequent suture anchor 220. May be configured as a stop that protrudes into the central lumen of the delivery needle 210 and into some passages of the distal anchor 220a to prevent sliding from the delivery needle 210.

  More specifically, as shown in FIG. 2B, when the anvil 240 and the cantilever 216 are in their normal operating positions, the thicker radial dimension of the anvil 240 is 1 on the distal suture anchor 220a. Adapted to interfere with one or more anchor bridges 221 (or other displaceable sections of the various locking mechanisms described above). During deployment, the anvil 240 may, for example, move the distal suture anchor 220a distally so that the anchor bridge 221 presses against and rides over the anvil 240 and displaces the anvil 240 radially outward. May be displaced outwardly in the radial direction. During the suture lock sequence, the anvil 240 may be displaced radially inward, for example, by advancing the close-fit lock tube 260 over the anvil 240 and the delivery needle 210. Anchor locking tube 260 is withdrawn proximally along delivery needle 210 or presses anvil 240 radially inward into anchor 220a such that it exposes the needle tip for tissue penetration. The suture anchor 220a may be advanced distally toward the needle tip to lock the suture anchor 220a to the suture 230.

  System 200 also provides for the advancement of one or more suture anchors 220 through delivery needle 210 in an axial or longitudinal direction and to prevent anchor 220 from sliding back from delivery needle 210. In addition, a push rod 250 may be included. As shown in FIG. 2C, the push rod 250 moves the suture anchor 220a distally so that the distal anchor bridge 221 slides along and rides over the inwardly facing surface of the anvil 240. You may move forward. When sufficient force is applied to the anchor 220a by the push rod 250, the bridge 221 displaces the anvil 240 radially outward, resulting in a portion of the anvil 240 protruding radially from the outer surface of the delivery needle 210. . Advantageously, in some variations, the push rod 250 is integrated into the proximal suture anchor 220b to prevent relative rotation of the anchors 220a, 220b within the lumen of the delivery needle 210. An anti-rotation key 255 may be included that is adapted to mate with an anti-rotation feature.

  The push rod 250 may be grooved or hollow, so that the suture 230 may extend slidably through the push rod 250 as well as through the suture anchor 220 and delivery needle 210. In one embodiment, as illustrated in FIG. 2C, delivery needle 210, each anchor 220, and suture 230 are aligned substantially coaxially. In some embodiments, one end of the suture 230 may have a delivery needle such that the suture seam can be tightened, for example, so that it can be manually accessible to a surgeon or other medical personnel. 210 and the proximal end of the locking tube 260 may extend. In other embodiments, the proximal section of the suture 230 may be mechanically gripped and the seam is via a pulling mechanism included within a surgical tool, such as a tool described in more detail below. It may be tightened.

  In certain situations, for example, when preparing an anchor for deployment through a tissue layer, the distal suture anchor is held while the suture anchor 220a is fully retained within the delivery needle 210, as shown in FIG. 2C. It may be preferable to advance 220a a sufficient distance for the anvil 240 to deflect radially. As shown in FIG. 2D, once the distal suture anchor 220 a is pushed close to the opening of the delivery needle 210, the locking tube 260 is locked to the distal end of the delivery needle 210. As the inner surface of the locking tube 260 protrudes radially inward, thereby deforming one or more anchor bridges 221 and, advantageously, distally It may be advanced distally to lock the anchor 220a to the suture 230. As shown in FIG. 2E, after locking the suture 230 within the distal suture anchor 220a, the locking tube 260 may be removed, for example, by retracting it back proximally. Naturally, other anchor locking mechanisms can be similarly actuated by the cooperation of push rod 250, anvil 240, and locking tube 260.

  Referring to FIGS. 2F-2H, an alternative embodiment of a needle delivery system that does not include a locking tube is shown. The needle delivery system includes a delivery needle 210 and an anvil 240. A plurality of suture anchors 220a and 220b (eg, suture anchor 300C depicted in FIG. 3G) may be disposed within the central lumen of delivery needle 210, eg, end to end. The anvil 240 is constructed and arranged to mechanically interfere with the cantilever tabs 521 of each suture anchor 220a, 220b and prevent the anchors 220a, 220b from sliding from the open end of the delivery needle 210. . In some applications, the anvil 240 is cylindrical or substantially cylindrical in shape and has an outer diameter that is dimensioned so as not to mechanically interfere with the sidewall 524 (see FIG. 3G) of the anchor 300C. More specifically, as shown in FIG. 2G, when the most distal suture anchor 220a is biased distally, for example, by a push rod 250, the anvil 240 has a bent or deformed tab 521. The cantilever tab 521 is bent or deformed radially inwardly into a portion of the suture so as to lock the suture to the anchor 220a.

  In some implementations, the anvil 240 and anchor 220a further advance adjacent distal anchors 220a within the needle bevel 299 of the delivery needle 210 by advancing the distal most anchor 220a by the length of one anchor. It is sized so that the junction point 599 is placed between 220b. As shown in FIG. 2H, once the suture is locked to the distal-most anchor 220a and the anchor 220a is deployed, the deployed anchor 220a can, for example, apply tension to both ends of the suture. May be rotated from the longitudinal axis of the system. By applying tension to the suture thread, the deployed anchor 220a rotates about the joint point 599 within the needle oblique angle 299.

  In some surgical procedures, a plurality, eg, a pair of locked suture anchors, connected by a fixed length of suture may be preferred. Those skilled in the art will appreciate that such anchored suture systems can be prefabricated in lots having a particular length, or can be produced individually during and as part of a surgical procedure. Let's go.

  Referring to FIG. 2I, an embodiment of an anchor delivery system for such an application is shown. The delivery system includes a delivery needle 210 and a push rod 250. Disposed within the longitudinal central lumen of needle 210 is a pair of locked suture anchors 270, 280 that are interconnected by a fixed length of suture 275. The pair of distal anchors 270 and proximal anchors 280 may also be further mechanically coupled to each other using, for example, a breakable connector, such as the type discussed in more detail above.

  Only a single pair of suture anchors 270, 280 is shown in FIG. 2I, but this is shown for purposes of illustration and not limitation. Multiple pairs of anchors may be included in the delivery needle 210, for example in a row. In some implementations, when there are multiple pairs of anchors 270, 280 within a single delivery needle 210, adjacent anchor pairs are advanced or withdrawn as a single more controllable unit with a combined anchor pair. As may be done, for example, it may be coupled using a breakable connector 288, eg, of the type discussed in more detail above. The proximal pair of anchors may also be coupled to push rod 250 by a breakable connector 288.

  FIG. 2J shows a pair of anchors 270, 280 that approximate the tissue. In some applications, a first anchor 270 is delivered through a pair of tissue walls 805a, 805b and deployed in a distal lumen, while a second anchor 280 is deployed in a proximal lumen. The The fixed length suture 275 that connects the pair of anchors 270, 280 is such that once the second anchor 280 is deployed, the tension in the suture 275 causes the anchors 270, 280 to move into the tissue walls 805a, 805b. They are sized so that they can be pressed together.

  The features of the delivery system and their function will now be described in conjunction with describing an exemplary embodiment of a method for delivering a suture anchor and suture in a mammalian subject as part of a surgical procedure. Is done. Referring to FIGS. 10A and 10B, sutures 630, 830 in which tissue penetration, anchor delivery, and anchor deployment are locked into suture anchors 620, 800 prior to delivery / deployment of anchors 620, 800, or It may be implemented using any of the sutures 630, 830 that are unlocked within the suture anchors 620, 800. The tissue 805 (FIG. 10C) to which the anchors 620, 800 can be delivered includes relatively soft tissues such as portions of the GI tract (eg, stomach and intestine), muscle (eg, abdominal muscle) layers, tendons, ligaments, cartilage, and the like. May be included. Alternatively, tissue 805 may be hard tissue, such as cortical bone, and suture anchors 620, 800 may be configured to deploy within relatively soft tissue, such as cancellous bone. Embodiments of delivery needles 610, 810, configured to deliver anchors 620, 800 through a layer of hard tissue 805 through a pre-drilled hole, the anchors 620, 800 can be lumened upon delivery. An unsharpened tip with a distal section protruding into the needle lumen may be included so as to be urged radially outward from. Accessing the tissue site 805 may involve advancing the delivery needles 610, 810 through the instrument channel of the endoscope.

  FIG. 10A depicts an illustrative embodiment of the former case in which a suture anchor delivery system 600 that includes a delivery needle 610 is configured to deliver a locked suture anchor 620 longitudinally through tissue 805. To do. The suture anchor 620 remains completely within the lumen of the delivery needle 610 with the body of the anchor 620 ready for locking to the suture 630 while one or more anchor bridges are under the anvil 640. , Shown in an enclosed locking position. As previously described, the delivery needle 610 may include an anvil slot 615 in which the anvil 640 can be supported at the end of the cantilever 616. In some variations, the anvil 640 is positioned proximal to the needle tip, eg, the needle bevel 616, leaving a distal space in the slot 615 where the suture 630 can fold to assist in tissue penetration. , Lateral support for suture cutting (described below) may be provided. As shown in FIG. 2D, prior to penetrating tissue 805, locking tube 260 is translated distally over delivery needle 210 to press anvil 240 into bridge 221 of anchor 220a and suture anchor 220a. May be locked to the suture 230 (step 1).

  Alternatively, FIG. 10B is an illustration of the latter case where a suture anchor delivery system 850 including a delivery needle 810 is configured to deliver an encapsulated and unlocked suture anchor 800 through tissue 805. An embodiment is shown. As shown in FIG. 10B, when delivering an unlocked suture anchor 800, the suture anchor 800 is completely within the lumen of the delivery needle 810, a distance from the opening at the needle bevel 616. Stay. In some variations, the anvil 640 is disposed proximal to the needle tip, eg, the needle bevel 616, leaving a distal space in the slot 615 where the suture 830 can fold to assist in tissue penetration. Lateral support for suture cutting may be provided.

  Delivery and deployment of one or more suture anchors 620, 800 is illustratively shown in FIGS. 10C-10G with or without sutures locked within the suture anchors. Initially, delivery needles 610, 810 may be inserted through tissue 805 to the desired depth (step 2). In some implementations, during delivery (step 2), the sutures 630, 830 may extend proximally within the anchors 620, 800 and distally outside the delivery needles 610, 810. Once delivery needles 610, 810 have been advanced to the desired depth (step 2), first suture anchor 620, 800 uses, for example, push rod 250 to bias suture anchor 620, 800. Thus, it may be biased from the lumen of the delivery needles 610, 810 and deployed behind the tissue layer 805 (step 3) (FIG. 10D). In some applications, suture anchors 620, 800 may be deployed within a portion of thicker tissue 805.

  Once the first or any subsequent suture anchor 620,800 is deployed (step 3) (FIG. 10D), the delivery needles 610,810 are removed from the back of the tissue 805, as shown in FIG. 10E. (Step 4). One skilled in the art will recognize that the optional locking action (step 1) and delivery action (step 2) may be performed while the first suture anchors 620, 800 are deployed, particularly when biased by the push rod 250. It will be appreciated that prior to being implemented, the second suture anchor 801 is displaced to the position where the first suture anchors 620, 800 were. Thus, after removal of the device from the back of the tissue 805, as shown in FIGS. 10F and 10G, the second suture anchor 801 may already overlap the sharp portion of the needles 610, 810, The anchor bridge of the two suture anchors 801 may already mechanically interfere with the anvil 815 and force the anvil 815 radially outward. If for some reason the device is not originally filled with a plurality of suture anchors, or a suture anchor needs to be added in succession, the second or subsequent suture anchor 801 may have a suture anchor 801 with a needle 610. 810, 810, overlaps the sharp portion of the delivery needle 610, 810 until the anchor bridge of the suture anchor 801 mechanically interferes with the anvil 815 and urges the anvil 815 radially outward. You may move forward. At this point, the sutures 630, 830 may or may not be locked in the advanced suture anchor 801, as described in conjunction with steps 2-4. A state that can be delivered and deployed in the same manner.

  In some implementations, the selectively lockable suture anchors 620, 800 can be similar to the suture anchors 620, 800, but without one or more side tissue supports. It may be strengthened using the lock 700. Referring to FIGS. 11A and 11B, a suture lock 700 is described above with respect to locking features such as a deformable bridge 703 and one or more suture recesses 704, toothed slots, or various anchor configurations. Any combination of such suture locking features may be included. The suture lock 700 may also form a lumen 705. Anchor bridge 703 and lumen 705 provide a passage and mechanical clearance through which the suture can travel freely and slidably bidirectionally. Advantageously, the bridge 703 may be configured to slidably receive the suture in the unlocked state and affix to the suture in the locked state. The suture lock 700 is also configured to mate with a corresponding anti-rotation feature integrated into the suture anchors 620, 800 and / or push rod 250 and a male anti-rotation key 701 and a female anti-rotation key. 702 may be included.

  The suture lock 700 may be delivered and deployed in a manner similar to the locked suture anchor 620. For example, in some applications, after the unlocked suture anchor 800 is delivered and deployed on the distal side of the tissue 805, the suture lock 700 engages the suture 730 within the suture lock 700. After being stopped, it may be deployed on the same side of tissue 805. Advantageously, combining the suture lock 700 with the unlocked suture anchor 800 on the same, eg, distal, side of the tissue layer 805, allows the surgeon or other medical personnel to first lock. The released suture anchor 800 can be deployed (the suture 730 is free to move), and then the suture 730 can be tensioned before the suture lock 700 and the suture 730 are affixed together. To. As shown in FIG. 11B, a series of suture anchors 720a, 720b and a suture lock 700 may be contained within the delivery needle 710, for example in a row, with a coaxial portion of the suture 730. FIG. 11B shows a suture lock 700 disposed between the first suture anchor 720a and the second suture anchor 720b, which is shown for illustrative purposes only. Advantageously, the surgeon using the device may include any number of suture locks 700, including zero, between the suture anchors 720a, 720b as required by the medical procedure.

  In some applications, the nature of the procedure may require tensioning the suture, which may require, for example, drawing tissue 805 toward the flat surface of needle bevel 616. As shown in FIGS. 10H to 10K, the suture 830 is tensioned by retracting the suture 830 proximally through the delivery needle 810 to bring the tissue layer 805 into contact with the second suture anchor 801. It may be applied (FIG. 10I). As shown in FIGS. 10J and 10K, the second suture anchor 801 is such that the distal portion of the anchor 800 overlaps the sharp portion of the delivery needle 810 while the anchor bridge remains under the anvil 815. , May be placed at a more distal location within the delivery needle 810. In this configuration, the suture 830 is withdrawn through the needle 810 and the anchor 801 while the tissue 805 is simultaneously pulled against the needle bevel 616 protected by the overlapping portion of the anchor 801 and tensioned to the seam. You may spend. Once the appropriate amount of tension is added, the locking tube 840 is advanced distally over the delivery needle 810, mechanically interfering with the anvil 815, pushing it radially inward, and Thus, the second suture anchor 801 may be locked to the suture 830. The second suture anchor 801 may then be deployed in the same manner as described in conjunction with steps 2-4.

  Once the desired number of anchors has been deployed, the suture may be cut (as the procedure may require) (step 5). Referring to FIGS. 10L-10N, the locking tube 660 may include a recessed edge 665 that allows the suture 630 to be cut (step 5). For example, in some embodiments, the cutting edge 665 is used to cut the suture 630 circumferentially as the locking tube 660 is advanced distally and then rotated about its longitudinal axis. May be configured. In an alternative embodiment, the cutting edge 665 may be configured to cut the suture 630 along the longitudinal direction, or both in the longitudinal and circumferential directions. The suture 630 may protrude from the anvil slot 615 for circumferential support during cutting, or it may protrude from the needle bevel 616 and be supported by a portion of the bevel 616. Locking the anchor 620 in the delivery needle and then cutting the suture 630 is advantageous when finishing the seam and preparing to start another.

  An alternative suture cutting structure is shown in FIG. With respect to this embodiment, the locking tube 660 may include a cutting edge 665 that allows cutting the suture 630 disposed within the suture cutting notch 663 of the delivery needle 610 (see FIG. Step 5). Advantageously, the cutting edge 665 is configured to cut the suture 630 longitudinally without rotation as the locking tube 660 is advanced distally. More specifically, suture 630 may protrude from a suture cut notch 663 formed in delivery needle 610 and / or needle bevel 616. The suture cutting notch 663 may also be sharp to assist in cutting the suture 630.

  The embodiment of the suture anchor and delivery system detailed in FIGS. 10A-10O is a longer, more flexible format suitable for flexible endoscopy applications within the scope of the present invention. May be implemented. Shorter rigid systems may be advantageously employed in procedures with more direct access, such as various laparoscopic procedures.

  An illustrative use of the device will now be described. Those skilled in the art will appreciate that the exemplary use is for purposes of illustration and not limitation. Those skilled in the art will also appreciate the myriad uses of the device. Advantageously, the device may be used for both interrupted and continuous suture placement, allowing the same device to place one or more interrupted or continuous sutures.

  A first exemplary use to approximate the tissue plane using the needle delivery system 600 depicted in FIG. 10A is depicted in FIGS. 12A-12E. From a proximal lumen 804 in the body structure, the needle delivery system 600 is penetrated into a second distal lumen 806 in the body structure, for example, from the stomach into the jejunum. A suture locking structure associated with the most distal suture anchor 620 in the delivery system 600 before and after penetration of the lumen walls 805a and 805b across the desired tissue plane is at the distal end 619 of the delivery needle 610. It may be selectively engaged, i.e. locked (steps 1 and 2) (Fig. 12A), by the anvil 640 located towards it. This locks the suture 630 to this particular suture anchor 620. The suture anchor 620 is then advanced, ie, deployed (step 3) (FIG. 12B) from the needle delivery system 600 along with the locked suture. The needle delivery system 600 may then be withdrawn back to the proximal lumen 804 (step 4) (FIG. 12C), leaving the distal suture anchor 620 in the second distal lumen 806. The suture 630 extending along the length of the undeployed anchors 601, 602 in the delivery system 600 is not tensioned and extends freely from the delivery system 600 during needle tip removal.

  The next sequence of suture anchors 601 in the delivery system 600 is then moved toward the distal tip 619 of the delivery needle 610 without the distal end of the anchor 601 being fully advanced from the delivery system 600 ( FIG. 12C) may be advanced to a position that extends to cover the sharp edge of the needle tip. In such a position, with some forward or steady force on the delivery system 600 so that the tension approximates the two lumen walls 805a, 805b (FIG. 12D) without causing trauma associated with the needle tip. , Can be applied to the proximal side of the slidable suture 630. The tension on the suture 630 can be manually operated by an operator or mechanically retracted, eg, a constant force spring loaded spool, an electric motor under feedback control, a manually operated suture reel attached to the handle of the delivery system (FIG. 14). Or via any suitable suture retraction mechanism.

  Once the suture 630 is sufficiently tightened so that the two lumen walls 805a, 805b are in the desired proximity, the suture locking structure on or near the next sequence of suture anchors 601 is For example, it may be engaged by an anvil 640 located towards the distal end of delivery system 600 (FIG. 12D). The present locking mechanism locks the suture 630 to the second anchor 601 in or near the proximal lumen wall 805a, thereby allowing suture tension and tissue between the two lumens 804, 806 to remain. The juxtaposition may be maintained. The second anchor 601 is then deployed, and the suture 630 may be cut proximate to the locking position near the second suture anchor 601 (step 5). The placement of a new suture using the next sequence of selectively engageable suture anchors 602 may then be initiated using the same steps as described above.

  Alternatively, another interrupted suture may be initiated without cutting the suture 630 as shown in FIG. 12E. Advantageously, this procedure allows loop formation of suture 630 between separate tightened and locked suture anchors that approximate two lumen walls 805a, 805b in multiple areas. Good. Tension is then applied to such looped suture formation, for example, bringing a trocar or other such device into proximity from the proximal lumen 804 to the distal lumen 806 to the lumen wall 805a. , 805b may be advanced.

  A second use of the needle delivery system 600 may involve an interrupted suture for use in closing a tissue defect or perforation, for example. In some implementations, the needle delivery system 600 is penetrated across the tissue plane on one side of the defect. The suture locking structure of the distal suture anchor 620 is engaged with the anvil 640 toward the distal end 619 of the delivery needle 610. The locking mechanism may lock the suture 630 to this particular suture anchor 620. Anchor 620, along with locked suture 630, may then be advanced from delivery needle 610 and deployed where desired. The needle 610 may then be removed from the tissue plane and leave the anchor 620 with the suture 630 locked to the distal side of the tissue plane across the penetration site. Delivery needle 610 may then be penetrated across the tissue plane on the opposite side of the defect. The next sequence (second) anchor 601 may then be advanced from the needle delivery system 600 without engaging the suture locking structure, ie, the anchor 601 remains unlocked. is there. The delivery needle 610 may then be removed leaving the fully unlocked anchor 601 with slidable suture 630 on the distal side above the tissue plane, on the opposite side of the defect.

  The next sequence (third) suture anchor 602 in the delivery system 600 may then be advanced toward the distal tip of the delivery needle 610, and thus the distal end of the present anchor 602 is delivered. It extends to cover the sharp edge of the needle tip without being fully advanced from the system 600. In such a position, tension can be applied to the proximal side of the slidable suture 630 to approximate the two sides of the defect without causing trauma associated with the needle tip. The suture lock structure may then be engaged, for example, by an anvil 640 located toward the distal end 619 of delivery system 600. This locks the suture 630 to the present anchor 602, thereby maintaining the suture tension between the anchors 620, 601, and 602 and aligning the two sides of the tissue defect or perforation together. The third anchor 602 may then be deployed and the suture 630 may be cut proximate to the locked position of the book (third) anchor 602. The placement of a new suture 630 may then be initiated.

  A particular application of the above method involves arthroscopic repair of meniscal cartilage rupture. As shown in FIG. 13, suture anchors 1004, 1005 are deployed in a vertical zigzag configuration and are deployed above or through tear 1011 in meniscal cartilage 1010, respectively, using continuous suture 1015. A continuous z-stitch repair may be formed. A series of anchors 1004, 1005, they rest on the cartilage outer surface 1012, the deployed initial anchor 1001 is locked, the deployed intermediate anchor 1002 is unlocked, and prior to deployment of the terminal anchor 1003. , May be deployed through the cartilage so that the z-stitch can be tightened. Alternatively, each anchor may be locked and the suture may be tightened as each anchor is deployed.

  In an alternative suture configuration, a suture anchor 1021 may be deployed at a series of interrupted stitches 1020, and both anchors 1021, eg, anchors above or through the tear, are locked. For both of these suture configurations, the cartilage may be approached from the meniscal surface to leave only the suture on the meniscal surface 1012 and to confirm complete closure of the tear under the endoscope.

  In another exemplary embodiment, the needle delivery system 600 depicted in FIG. 10A facilitates the use of continuous sutures. The suture lock structure may be engaged with the anvil 640 toward the distal end of the needle delivery system 600. This locking mechanism locks the suture 630 to the most distal anchor 620. Needle delivery system 600 may then penetrate across one or more tissue planes 805. Anchor 620, along with locked suture 630, may be advanced or deployed from delivery needle 610 to serve as a first anchor point for suture 630. The delivery needle 610 may then be removed leaving an anchor 620 with a locked suture 630 that traverses the penetrated tissue plane.

  Needle delivery system 600 may then penetrate across another side of the tissue plane. The next sequence of anchors 601 is advanced, i.e. unlocked, from the delivery needle 610 without engaging the suture locking mechanism. Delivery needle 610 may then be withdrawn, leaving the present anchor 601 with slidable suture 630 across the second penetration site on the distal side of the tissue plane. Additional penetrations across the various sides of the tissue plane may be made in the same manner when deemed necessary. A penetration with placement of a suture anchor with a continuously slidable suture 630 can be made in a purse, cross, z-shaped, or any similar pattern as desired.

  Once the continuous suture of the desired length and pattern is completed, the final anchor can be deployed. In some applications, this may be done using a needle delivery system 600 located on the proximal side of the tissue plane. The next sequence of (final) anchors will cover the sharp edges of the needle tip without the distal end of the anchor being fully advanced from the delivery system 600 toward the distal tip of the delivery needle 610. May be advanced to a position that extends to In such a position, tension is applied to the proximal side of the slidable suture 630 to tighten the continuous suture 630 between the suture anchors without causing trauma associated with the needle tip. Can do. The final anchor suture locking structure may then be engaged with an anvil 640 located toward the distal end of delivery system 600. The mechanism locks the suture 630 to the final anchor, thereby maintaining suture tension between the anchors and keeping the tissue plane penetrated with the plurality of suture anchors together. The final anchor may then be deployed and the suture 630 may be cut proximate the locked position of the final anchor. The placement of a new suture 630 may then be initiated.

  Another application of the present invention may include alternating suture anchors and suture locks. For example, referring to FIG. 11B, in some embodiments, the needle delivery system includes a series of alternating unlocking with a single suture lock 700 between each suture anchor 720a, 720b. Featured suture anchors 720a, 720b and suture lock 700. In use, the suture lock 700 may be affixed to the suture 730 or may remain slidably attached over the suture 730 if locking is not desired. Although more complex than embodiments that employ only lockable suture anchors, this configuration provides a terminal suture before the suture 730 is tensioned and the suture lock 700 is affixed to the suture 730. It may be advantageous to allow the thread anchor to withdraw completely from the delivery needle 710. Further, the suture anchors 720a, 720b under tension can optionally be placed on either the proximal or distal surface of the tissue 805 being sutured.

  FIG. 14 shows that a suture 1130 extends slidably through a respective lumen of a series of suture anchors 1140, an optional suture lock, and a push rod 1120 contained at least partially within the delivery needle 1110. 8 depicts an embodiment of a hand-held and manually actuable suture anchor delivery system 1100 that may be. In some variations, drag friction between the suture reel 1135 and the support handle 1150 prevents the suture reel 1135 from freely rotating suddenly, for example when the suture 1130 is not actively pulled. May be desired. A suture 1130, suture anchor 1140, optional suture lock, and push rod 1120 extending through the delivery needle 1110 serve as a reservoir of available suture 1130 as shown, as shown. May be retracted and / or tensioned, for example, by rotating it counterclockwise. The suture reel 1135 is for easy access by the thumb of the user's hand supporting the delivery system 1100, in particular for rotation of the reel 1135 to retract and / or tension the suture 1130. A configured knurled thumbwheel 1136 may be included.

  In some implementations, the tension on the suture 1130 is maintained by a spring loaded ratcheting reel lock 1137, a portion of which can act as a pawl for engaging a tooth feature in the suture reel 1135. Also good. In use, in some applications, tension in the suture 1130 can be released by depressing the lever portion of the reel lock 1137 and disengage the pawl portion of the reel lock 1137 from the suture annulus. Advantageously, this allows the user to release the relaxed suture 1130 from the distal end of the delivery needle 1110 when the delivery system 1100 is removed.

  In use, the anchor anchor 1140 and / or the suture lock is constructed and arranged to advance or propel the push rod slider 1121 and push rod pawl 1122 toward the distal end of the delivery system 1100. 1125, for example, may be advanced distally within the delivery needle 1110 by actuating a finger pull loop. In some embodiments, the push rod slider 1121 is operably coupled to the push rod 1120 by pawl 1122, for example by engaging longitudinally spaced tooth features on the push rod 1120. In some variations, the push rod 1120 may be enclosed within a portion of the handle 1150 to protect the push rod 1120 during use and handling.

  In some implementations, the handle 1150 is also constructed and arranged to direct the suture 1130 from the push rod 1120 to the suture reel 1135, which may be distal to the proximal end of the push rod 1120. A thread guide 1123 may be included.

  Once the most distal suture anchor 1140 in the delivery needle 1110 has been advanced sufficiently distally to force the anvil 1105 radially outward, the suture anchor 1140 may be anchored, for example, The locking tube 1115 activated by the lever 1116 may be locked to the suture 1130 by advancing distally. In some variations, actuation of the locking lever 1116 may cause the locking tube 1115 to urge the anvil 1105 radially inwardly and suture 1130 as described in more detail herein above. Locking tube slider 1118, which is coupled to locking tube 1115, is advanced or propelled distally so as to lock into the distal most anchor in delivery needle 1110. In the second stage of anchor locking lever actuation, which can be delimited by haptic feedback, the locking tube 1115 can be rotated on its axis so that the cutting edge 1117 presses against the suture 1130 and bisects it. Good. Other embodiments of the invention may include robot actuation instead of each manually actuated element. Suture reel feedback control, particularly tactile feedback, may be advantageous in robotic embodiments of the delivery system.

  Referring to FIGS. 15A-15C, a helical tissue control tool 500 for tissue retraction and control is shown in conjunction with the needle delivery system described above. In some embodiments, the tissue control tool 500 has a sharpened distal tip 502 attached to a catheter 503 having a central lumen 504 into which an instrument 505, for example, a needle delivery system 600 can be inserted and removed. A helical coke screw element 501. Such an instrument 505 may also include a tissue aspiration needle, biopsy forceps, injection needle, tissue access device, and cryotherapy or RF ablation probe. In some variations, the helical tip 502 engages the tissue plane using, for example, a rotational force or torque applied to the proximal end of the catheter 503 and uses the opposite rotational movement to disengage the tissue. It may be configured as follows.

  The shaft of device 500 is made of a rigid (for laparoscope) or flexible material (for endoscope), which can be made of metal, polymer, fiber reinforced composite, or other suitable material. Also good. As an example of use with a suture anchor tissue apposition tool 510 as shown in FIG. 15B, the tip 502 of the helical coke screw element 501 is pressed against the first target site 508 and one of the tissue defects 506 is placed. For example, it may be rotated clockwise so as to penetrate into the edge. Using tissue supported by the helical coke screw element 501, a medical device, eg, tissue apposition tool 510, may then be advanced through the central lumen 504 and through the supported tissue layer. Using the techniques and methods described above, one or more suture anchors are then anchored before the helical coke screw element 501 is rotated outwardly from the tissue, eg, counterclockwise. It may be delivered and deployed on the distal side of the tissue layer with or without selective sutures locked therein.

  As shown in FIG. 15C, device 500 and tissue apposition tool 510 with suture 507 still attached may then be repositioned to a second target site 509 on the opposite side of tissue defect 506. . With suture 507 extending from the initially deployed suture anchor, one or more additional suture anchors or locks may be delivered and deployed to the desired location in the tissue. .

  Referring to FIG. 15D, an alternative embodiment of the tissue control tool 500 is shown. The incision 511 may allow the tool 500 to both control tissue during needle penetration and sever the suture 530 after, for example, one or more suture anchors have been deployed. Integrated into the organization control tool 500. In some implementations, the cutting edge 511 is formed on a portion of the metal base 512, for example, to which the helical coke screw element 501 is attached. In some variations, the cutting edge 511 is beveled radially inward, and thus the cutting edge 511 is protected from the helical coke screw element 501.

  FIG. 16 depicts a table of geometry and other parameters for various embodiments of anchors, suture locks, sutures, and delivery needles. The quantities and values are not necessarily limiting and should be considered illustrative of exemplary embodiments. Various applications may require larger or smaller components and delivery systems, which are within the scope of the present invention.

  Those skilled in the art will appreciate that the present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The foregoing embodiments are therefore to be regarded in an illustrative manner rather than a limitation of the invention described herein in all respects together with the accompanying drawings.

Claims (41)

A suture tether system,
A longitudinal axis extending from the proximal end to the distal end of the anchor and a displaceable section for locking a portion of the suture, wherein the length of the locked suture portion is A suture anchoring system comprising an extension anchor extending in the direction of the longitudinal axis.   The system of claim 1, wherein the displaceable section comprises at least one of a plastically deformable material and an elastically deformable material.   The displaceable section includes a suture loop, a suture locking tab, a deformable connecting element, a suture engaging slot, a suture engaging tooth, a deflectable locking projection, a bridge element, and a deformation. The system of claim 1, comprising a structure selected from the group consisting of possible struts and cantilever tabs.   The system of claim 1, wherein the anchor further comprises a fixation section comprising at least one feature for engaging the suture.   The system of claim 4, wherein the at least one feature comprises a friction enhancing feature selected from the group consisting of a suture engagement slot, a suture engagement tooth, and a securing tab.   The system of claim 1, wherein the anchor further comprises a plurality of tissue supports.   The system of claim 1, wherein the anchor further comprises an anti-rotation key engageable with a corresponding anti-rotation key of another anchor.   The anchor of claim 1 further comprising a beveled distal tip and a connector interlockable with a corresponding connector of another anchor to allow rotation of the anchor in a single plane. System.   The system of claim 1, wherein the anchor further comprises at least one of a sharp distal tip and a blunt shoulder proximate to the distal tip.   The system of claim 1, wherein the anchor defines a lumen for slidably receiving the suture.   The system of claim 1, wherein the anchor defines at least one suture recess for receiving a portion of the suture.   The system of claim 1, further comprising the suture.   The system of claim 12, wherein at least one of the anchor and the suture comprises a bioabsorbable material. A system for delivering a suture anchor, comprising:
A delivery needle;
An anvil coupled to the delivery needle to lock the anchor to a suture within the delivery needle;
A system comprising: A plurality of anchors positioned within the delivery needle;
The suture extending slidably through the plurality of anchors;
15. The system of claim 14, further comprising:   The system of claim 15, wherein the delivery needle, each anchor, and the suture are aligned substantially coaxially.   The system of claim 15, further comprising a breakable connector between each anchor.   The system of claim 17, wherein each anchor comprises an engagement / disengagement shoulder at a proximal end and a distal end of the anchor.   The system of claim 15, further comprising a push rod for advancing the plurality of anchors through the delivery needle.   The system of claim 19, wherein the push rod comprises an anti-rotation key that can engage with a corresponding anti-rotation key of an anchor.   The system of claim 15, further comprising a mechanism for at least one of retracting, tensioning, and releasing the suture.   The system of claim 14, further comprising a locking tube movable with respect to the delivery needle to actuate the anvil.   The system of claim 22, wherein the locking tube comprises a cutting edge.   15. The system of claim 14, wherein the delivery needle defines a longitudinal slot for engaging an anchor protruding tab.   The system of claim 14, wherein the delivery needle comprises a sharp distal tip.   The system of claim 14, wherein the delivery needle comprises a suture cut notch. A method for suturing tissue,
Using the anvil to lock the anchor to the suture within the delivery needle;
Deploying the anchor from the delivery needle to a tissue site;
Including the method.   28. The method of claim 27, wherein using the anvil includes actuating the anvil by displacing a locking tube relative to the anvil.   28. The method of claim 27, wherein using the anvil includes mechanically interfering the anvil with a displaceable section of the anchor.   30. The method of claim 29, wherein mechanically interfering the anvil with the displaceable section of the anchor comprises displacing the anchor using a push rod.   28. The method of claim 27, further comprising displacing the locking tube to cut the suture.   The step of displacing the locking tube to cut the suture includes the step of moving the locking tube longitudinally along the longitudinal axis of the delivery needle and rotating the locking tube. 32. The method of claim 31, comprising at least one of:   28. The method of claim 27, further comprising advancing the delivery needle through the instrument channel of an endoscope to the tissue site.   To perform at least one of approaching a tissue layer, approaching two separate lumens in a patient's body, closing a defect at the tissue site, and securing a medical device at the tissue site, 28. The method of claim 27, further comprising using the suture.   35. The method of claim 34, wherein the medical device is selected from the group consisting of a stent, a physiological sensor, a camera, and a surgical mesh. A tissue engagement tool,
A catheter comprising a lumen for receiving a medical device;
A cutting edge coupled to the distal end of the catheter;
A helical coke screw element coupled to the distal end of the catheter;
A tissue engagement tool comprising:   37. The tissue engaging tool of claim 36, wherein the incision is beveled radially inward.   38. The tissue engaging tool of claim 36, wherein the helical coke screw element comprises a sharp distal tip for engaging tissue. A method for engaging tissue, comprising:
Inserting a tissue engagement tool proximate a tissue site, the tissue engagement tool comprising a catheter and a helical coke screw element coupled to a distal end of the catheter;
Rotating the helical coke screw element to engage the tissue site;
Then delivering a medical device to the tissue site through the lumen of the catheter;
Including the method.   40. The method of claim 39, further comprising cutting a suture using a cutting edge coupled to a distal end of the catheter.   40. The device of claim 39, wherein the medical instrument is a device selected from the group consisting of a tissue access device, a tissue suction needle, a biopsy forceps, an injection needle, a cryotherapy probe, and an RF ablation probe. Method.